The present invention relates to a support device for use in suturless anastomosis procedures, and a method for performing suturless anastomosis. The method according to the invention will be referred to in the present specification as IKF-IS technique (Institutt for Kirurgisk Forskning-Intervensjonssenteret).
The risk inherent in the performance of conventional cardiopulmonary bypass grafting (CABG) and the relatively frequent need for reintervention after percutaneous transluminal coronary angioplasty (PTCA) have caused a rising interest in developing thoracoscopy assisted procedures that combine the patient-friendly nature of PTCA with the durable benefits offered by CABG.
Three approaches are currently undergoing evaluation, none of which eliminate the need for both cardiopulmonary bypass and thoracotomy. As these two procedures represent the primary causes of morbidity after CABG, there is an urgent need for developing a minimally invasive procedure that can be performed on a beating heart, entirely under endoscopic-fluoroscopic guidance.
The IKF-IS technique has been envisaged to meet this need.
An important feature of this technique is that its use is not limited to the coronary arteries. An IKF-IS anastomosis can be done in any vascular area within reach of an endoscope. The range of use includes also extravascular tubular structures such as the esophagus, intestines, ureter, biliary ducts and fallopian tubes.
Suturless anastomosis of vessels is not a new concept. A large number of anastomosis devices has been described in literature, though few of them have passed the test of time.
Structurally sound anastomosis between vessels can be rapidly established simply by apposing the vessel ends with interlocking external collars.
GB-B-1.413.191 describes a device for the eversion of hollow organs and a vascular stapling instrument incorporating same. The device optionally comprises a rigid bush with a longitudinal slot or a rigid split bush comprising two pivotally connected half-bushes which can be mechanically disengaged from each other. The bush forms an integral part of an instrument used to evert the cut edges of the limbs of the tubular organ to be anastomosed and temporarily approximate them so as to facilitate suturing or placement of clips that will hold the edges together. When the clips are in place, the instrument and the bush are removed. Thus the device simply acts as an aid to the creation of an anastomosis and in no way removes the drawbacks to using sutures and clips for creating anastomoses.
U.S. Pat. No. 4,917,087 describes devices, kits and methods for non-suture end-to-end and end-to-side anastomosis that employ tubular connection members having clip retaining elements and spring clips which comprise a ring-shaped body with separable opposed ends whereby a circular opening defined by the body can be enlarged.
Unfortunately, these anastomosis devices and others available today were designed for use at open surgery and are not appropriate for endoscopic placement.
EP-A-781.528 describes a fastener for connecting severed blood vessels. The device has a plurality of miniature barbs which pierce the wall of the blood vessel and anchor the fastener in place. In one embodiment the fastener comprises a sheet provided on one of its surfaces with a plurality of barbs, the sheet can be rolled to a diameter smaller than that of the blood vessel, inserted into the blood vessel and unrolled so that the barbs pierce and anchor in the inner wall of the blood vessel. The sheet can alternatively be wrapped round the blood vessel so that the barbs pierce and anchor to the outer wall of the blood vessel. The bond strength of the device as tested is not adequate for clinical use, because the biologic response is not appropriate or the design does not provide the structural strength to tolerate the expected loading forces (whether in shear or in tension is not specified in the document) at the interface between the device and the vessel surface. The penetration of the vessel wall by the barbs on the device can cause separation of the layers of the vessel wall, which in turn can lead to thrombus formation or dissection at the site. The damage to the vessel wall would logically be even more severe if the size of the barbs is increased. Barbs which spontaneously retract, will leave behind holes in the vessel wall from which bleeding could occur. From the description provided in claims 1 and 2, it does not seem possible that these embodiments of the device lend themselves to use via an endoscope. Besides, it is unclear how the barbs will be prevented from inadvertedly engaging the adjacent overlying layer as the device is being unfolded by the balloon.
Furthermore WO 98/52474, WO 94/27506, demonstrate devices for performing anastomosis, with and without eversion of the blood vessel respectively, while U.S. Pat. No. 5,254,113 describes the use of strips for anastomosis of intestines. None of these publications do, however, describe a sleeve and use of a sleeve to evert the blood vessels, use of a transitional temperature range (TTR) material in an anastomosis device and an anastomosis device provided with metal collars. In addition, the use of these devices involves the retention of an intraluminal foreign body after anastomosis creation in direct contradiction to the invention in the present application.
FR-A-1.518.083 describes a device for performing end to end and end to side anastomosis. In the embodiment adapted for end to side anastomosis, the device comprises a curved plate with a bore and a joint surrounding the bore. The plate is glued to a first vessel, a hole is cut in said vessel corresponding to said bore in the plate, and a muff containing the second vessel is attached to the joint. The curved plate simply provides a surface area for the adhesive used to attach the joint to the first vessel. Said plate does not permit fastening to the first vessel solely by mechanical means without an adhesive. It does not offer any self-attaching capability. Hence, in case of adhesive failure during the healing process, the curved plate will get dislodged with possibly catastrophic consequences.
An alternative method that has recently been successfully used for coronary artery bypass grafting on a beating heart is the Tulleken technique. By the incorporation of excimer laser arteriotomy, this technique permits the creation of end-to-end bypass without interrupting flow in the diseased vessel. However at its present stage of development, performance of a Tulleken anastomosis via an endoscope is not feasible. The high costs related to the use of excimer lasers further restrict the benefits of the Tulleken technique from the perspective of minimally invasive coronary artery surgery.
The object of the present invention is therefore to provide a device that permits creation of a suturless anastomosis between vessels via an endoscope. This object is achieved by means of a device comprising at least one tubular member, and characterized in that the tubular member is provided with a longitudinal slit, which slit permits introduction of the anastomosed vessels in the device, and the device is adapted for attachment to the vessel without any damage to the vessels"" walls.
The need for suturing is entirely eliminated by the invention, reducing danger of vascular trauma.
The anastomosis is exteiiiuy supported by the device according to the invention, this reduces the risk of acute structural failure, delayed aneurysm formation and in the presence of compliance mismatch, improves the long-term patency rate.